药品经营企业冷链管理检查体系的构建  

The Construction of Cold Chain Management Inspection System for Drug Business Enterprises

作　　者：黄炳生 吴生齐 丘杏柳 侯珺 HUANG Bingsheng;WU Shengqi;QIU Xingliu;HOU Jun(Guangdong Provincial Drug Administration Review and Certification Center,Guangzhou,Guangdong Province,510080 China;Review and Certification Center of Guangzhou Food and Drug Administration,Guangzhou,Guang-dong Province,510000 China)

机构地区：[1]广东省药品监督管理局审评认证中心,广东广州510080 [2]广州市食品药品监督管理局审评认证中心,广东广州510000

出　　处：《中国卫生产业》2023年第8期211-215,共5页China Health Industry

摘　　要：药品冷链管理是药品经营企业质量管理的重点,同时也是保证药品质量安全和公众健康的关键环节。如何加强药品经营企业冷链药品的监管,及时发现企业存在的问题是药品监管部门一直以来研究的课题。基于此,本文简要分析了药品经营企业冷链管理常见的问题,并探索出具有科学性策略的冷链管理检查体系,以期为药品监管部门进行针对性检查提供参考。The cold chain management of drugs is the focus of quality management of drug business enterprises,and it is also a key link to ensure the quality and safety of drugs and public health.How to strengthen the supervision of cold chain drugs in drug business enterprises and timely find out the problems of enterprises is a topic that has been studied by drug regulatory departments.Based on this,this paper briefly analyzes the common problems of cold chain management of drug business enterprises and explores the cold chain management inspection system with scientific strategies,in order to provide reference for the drug regulatory departments to conduct targeted inspections.

关 键 词：药品经营企业 冷链管理药品 现场检查 

分 类 号：R19[医药卫生—卫生事业管理]